www.fdanews.com/articles/185368-mhra-clears-trial-for-inhaled-pulmazole
MHRA Clears Trial for Inhaled Pulmazole
January 25, 2018
The UK’s Medicines and Healthcare Products Regulatory Agency signed off on Pulmatrix’s first-in-human study for an inhaled formulation of intraconazole.
The company will enroll 42 patients in a Phase I study to assess its drug Pulmazole’s safety and tolerability in patients with mild to moderate stable asthma. The inhaled formulation would be indicated for allergic bronchopulmonary aspergillosis.
Pulmatrix expects top-line results from the study by mid-2018. The company has already begun screening subjects, according to chief medical officer James Roach.